Seth C. Kalichman - US grants

Rates of HIV infection continue to rise in U.S. inner-cities, particularly among young ethnic minority men and women. Research has consistently demonstrated that prevention programs derived from social learning theory and based on cognitive behavioral skills training principles can produce HIV-risk reduction behavior changes. Unfortunately, cognitive behavioral interventions tested to date have relied on professional interventionists for implementation in face-to-face formats, making them difficult to transfer to community-based organizations. This application requests four years of support to develop, implement, and evaluate a behavioral skills training HIV prevention intervention to be delivered by videotape and community group facilitators to inner-city African-American men. The proposed research will begin with a 6-month period of formative study to expand our preliminary studies of situations and circumstances related to HIV-risk among young African-American men and to identify culture and gender themes for use in developing videotape contexts. The second half of the first year will be used to develop and produce two sets of videotapes: a five-session HIV prevention intervention using behavioral skills training techniques presented on videotape with subsequent group practice sessions facilitated by community group leaders; and a five-session videotape-based control condition focusing on social issues unrelated to AIDS and of relevance to inner-city men. Group sessions will be led by community-based organization staff who will be randomly assigned to intervention conditions and provided with group facilitation training. The intervention trial will be conducted at an inner-city neighborhood center, where 300 African-American men at recent risk for HIV infection will be randomly assigned to conditions. Assessments collected at baseline, post- intervention, 3-, 6-, 9-, and 12-month follow-ups will be used to determine relative intervention effects on AIDS-related knowledge, risk- related attitudes, intentions and self-efficacy to change behavior, and sexual risk behavior, as well as differences in communication skills and redemption of coupons to receive condoms. It is hypothesized that the HIV prevention intervention will result in increased behavioral skills relevant to HIV-risk reduction, decreases in unprotected sexual intercourse, and increases in condom use relative to the control condition. This research is intended to test the effects of a behavioral skills training intervention delivered by videotape that, if effective, could be readily disseminatable to community-based organizations.

While gay men have made significant changes in behavior to reduce risk for HIV infection, there is growing evidence that long-term consistent maintenance of change is difficult for many persons. Because of high HIV prevalence in this population, even infrequent lapses to high-risk behavior confer great risk for contracting or transmitting HIV infection. While relapse has been well-studied in other health behavior areas, there has been very little systematic attention to interventions intended to promote long-term HIV risk behavior change maintenance. In a formative research phase, the proposed study will use focus groups and individual elicitation interviews to identify critical situational, interpersonal, and intrapersonal factors associated with unsuccessful handling of risk behavior lapse urges as well as coping strategies used by homosexually- active men who have been able to successfully resist lapse temptations. The primary study phase will then test the relative impact of four interventions on long-term behavior change maintenance among 600 homosexually-active, continued-risk African-American and white men. Two of the intervention conditions involve 6-hour single group sessions that each include cognitive, attitudinal, and risk-reduction skills training; one of these time-matched interventions will also include specific, intensive training in relapse prevention. The other two conditions will follow the 6-hour core intervention with three group followup sessions and ongoing telephone contacts for 12 months; one of these extended-contact time- matched interventions will also include relapse prevention-training and have followup contacts focused on change maintenance issues while the other will not. This randomized intervention trial will follow participants for 33 months postintervention and utilize multivariate analyses to examine differential intervention impact on indices of risk knowledge, cognitive problem-solving and assertiveness skills relevant to risk reduction implementation, self-reported and self-monitored risk behavior, behavioral and attitudinal intentions, and STD incidence. It is hypothesized that the intervention conditions with specific relapse prevention components will produce, relative to the time-matched conditions without these elements, greater long-term maintenance of risk reduction behavior change. The design will also allow us to explore format, content, delivery, and duration of intervention needed to best promote long-term consistent change; these yet-unstudied issues are of practical importance to public health efforts to curb HIV. The overall intent of this research is to employ and test models for HIV risk reduction which are conceptually based on findings concerning relapse prevention in other health behavior areas and to identify promising intervention strategies for better preparing individuals for the long-term, consistent and perhaps lifelong behavior changes required for the continuing threat of HIV. In addition to HIV prevention, this study is expected to identify better approaches for the prevention of other STD's.

Multifaceted behavioral skills training interventions have demonstrated significant effects in reducing risk for HIV infection in high-risk populations. However, simultaneous inclusion of multiple intervention elements has precluded experimental analysis of specific skill component effects. The proposed study will recruit 100 men and 100 women from an inner-city STD clinic for participation in an intervention study to assess the independent and interactive effects of behavior self-management skills (e.g., cue identification and management, environmental manipulation, and cognitive restructuring), and sexual communication skills (e.g., sexual assertiveness, safer sex negotiation, and risk refusal skills). Participants will attend one of four different four session group interventions: (a) behavior self-management skills instruction only; (b)sexual communication skills instruction only; (c) a combination of both self-management and sexual communication skills; (d) a control condition without any skills instruction. Thus, the study will use a 2 (self- management skills/no self-management skills) X 2 (sexual communication skills/no sexual communication skills) complete factorial design with a 3- month follow-up assessment. It is hypothesized that while both skill components will evidence significant risk reduction, interaction effects of both skills will be most effective in reducing HIV risk. Analyses are also expected to show that the two skill components will have different patterns of effects for men and women, with men reducing risk to a greater degree in the behavior self-management skills condition and women evidencing greater risk reduction in the sexual communication skills condition. This study offers several implications for the development of HIV prevention interventions based on behavior skills training, including evidence for the efficacy of intensive instruction in specific skill components relative to the impact of multifaceted interventions. In addition, questions regarding the relative effects of specific skill components among men and women will be addressed.

The quality of HIV intervention research is dependent upon the reliable and valid measurement of behavior change. To the extent that study outcomes are demonstrated with measures that meet high scientific standards for reliability, validity, and conceptual relevance, we can have confidence in the behavior change effects produced by interventions. This core will support and stimulate basic research on assessment methodology through four functions: 1. Develop, pilot test, and evaluate existing data sets, and provide consultation of CAIR investigators in the areas of multidomain and multimethod assessment of sexual and substance use practices that confer risk for HIV infection, focusing particularly on measures to corroborate self-reports of behavior change and reliability and validity of these measures; 2. Develop, pilot test, and provide consultation to CAIR investigators on methods to tailor measure content and administration format to ensure cultural appropriateness for ethnic minority and low-reading level individuals; 3. Construct assessment measures related to intervention conceptual components in order to enrich opportunities to more precisely identify characteristics of interventions and mediators responsible for their behavior change effects; and 4. Establish a centralized system for efficient cohort tracking and followup location that can be used across multiple CAIR intervention outcome studies. This core will bring together a team of scientists experienced in behavioral, quantitative, and qualitative assessment research methods. The core will support the development, refinement, and adaptation of assessment methodologies and measures for use in existing and new CAIR investigators, will provide support and consultation to new investigators, and will conduct activities to stimulate improvements in research assessment methodologies.

Research has show that continued high-risk sexual practices among people with HIV infection are related to psychological distress, maladaptive coping, difficulty disclosing HIV serostatus to sex partners, and problems coping with high-risk situations. Although HIV risk reduction interventions based on theories of behavior change have been successfully applied to populations vulnerable to becoming HIV infected, there have been no published studies reporting outcomes from theory- based sexual behavior change interventions for HIV seropositive men. This application requests support to develop and test the effects of an HIV risk reduction intervention designed for HIV seropositive men who continue to practice unsafe sex. The proposed research will begin with a 6-month period of formative study to interview 50 HIV seropositive men and women concerning factors that facilitate and interfere with maintenance of safer sex practices. We will also pilot test our assessment instruments and procedures during this period. Beginning in the second half of the first year of study, we will initiate recruitment of 300 HIV seropositive men who will be randomized to one of two experimental conditions: 91) a 12 session with 3 booster sessions experimental HIV risk reduction intervention based on social cognitive theory of coping and behavior change. The intervention will include five major components; coping skills training, social support network development, communication and self-disclosure skills enhancement, sexual risk reduction skills enhancement, and relapse prevention; or (2) 12 sessions with 3 reunion sessions contact matched control condition which will be structured as a closed support group. The study will specifically test the effectiveness of an intensive, theory-based HIV coping and risk reduction intervention for men who already know they are HIV infected. An emphasis will also be placed on communication and self-disclosure skills enhancement, and relapse prevention. Assessments collected at baseline, immediately following the intervention, and again at 3-months, 6-months, 9-months, and 12-months following the intervention will be used to determine relative intervention effects on mental health, social support, sexual communication and sexual behavior change outcomes. It is hypothesized that the cognitive behavioral skills intervention will result in increased coping and social support compared to the social support group condition, and that the cognitive behavioral intervention will demonstrate increased self-efficacy, intentions, and acts of disclosing HIV serostatus to sex partners, as well as reduction in high-risk sexual practices and increased condom use, over a longer period of time than the support groups. This research will therefore test the effects of a cognitive behavioral coping and risk reduction skills intervention that, if effective, could be readily implemented by health care clinics and AIDS service organizations providing services to HIV seropositive men.

DESCRIPTION (adapted from the applicant's abstract): This application is in response to the Program Announcement "Coping with AIDS as a Chronic Long-Term Illness" (PA-99-026) and requests 3 years of support to develop and field-test an intervention to enhance HIV treatment adherence among persons with low-literacy skills. Guided by the Information-Motivation-Behavioral Skills model of health promoting behaviors and principles established for improving health behaviors in persons with low-literacy, we will conduct 3 phases of research: (1) Perform initial interviews and focus groups with HIV positive persons with low-literacy and their health care providers to establish barriers to treatment adherence and strategies to improve adherence for persons with low-literacy. This first phase of research will also develop informed consent and adherence assessment procedures for low-literacy populations; (2) Test the feasibility of a pictograph-based information, motivation, and behavioral skills building treatment adherence intervention with a small sample of persons with HIV infection who demonstrate poor literacy skills, and test the acceptability of the new intervention model with health care providers; and (3) Conduct a randomized field test to determine the potential efficacy of the pictograph-based intervention with 80 HIV seropositive persons with low-literacy. Participants in the field test will be randomly assigned to either receive the newly developed intervention or assigned to a wait-list comparison group. Following a six-month follow-up period, we will test for differences between groups on self-reported HIV treatment adherence measures as well as variables relevant to testing the Information, Motivation, Behavioral Skills adherence intervention model. Results of the proposed research will provide critical information about improving HIV treatment adherence with low-literacy populations that is needed prior to conducting larger and more expensive clinical trials.

DESCRIPTION: (Applicant's Abstract): This application is in response to the Program Announcement BRIEF INTERVENTIONS TO PREVENT THE SPREAD OF AIDS (PA 95-070) and requests 3 years of support to test brief HIV risk reduction counseling intervention models for men and women at risk for HIV and other sexually transmitted infections. Based on Fisher and Fisher's (1992) Information-Motivation-Behavioral Skills model (IMB), we will systematically manipulate two independent intervention components (motivational enhancement and risk reduction skills building) within the context of a single 60-minute face to face counseling session delivered to sexually transmitted disease (STD) clinic clients. We will recruit 400 women and 400 men from a city STD clinic who meet high-risk behavior criteria. Participants will be randomly assigned to 1 of 4 brief HIV risk reduction counseling experimental conditions: (a) a single 60-minute counseling session that delivers information about HIV sexual transmission risks, motivational enhancement counseling, and cognitive-behavioral skills for HIV risk reduction; or (b) a single 60-minute counseling session that delivers HIV risk reduction information and motivational enhancement without any cognitive-behavioral skills building components; or (c) a single 60-minute counseling session delivering risk reduction information and risk reduction skills building without motivational enhancement components; or (d) a single 60-minute counseling session delivering only HIV risk reduction information without motivational enhancement and without skills building components. Using the proposed 2 (motivational enhancement / no motivational enhancement) X 2 (behavioral skills building / no behavioral skills building) X 2 gender (male/female) complete factorial design we will assess the effects of brief counseling on incident sexually transmitted diseases, sexual risk behaviors, and condom use over 1-, 3-, 6-, and 12-month follow-up periods. We hypothesize that motivational and behavioral skills components will reduce risk, but a significant interaction will show the complete IMB intervention model is most effective in reducing STD and risk behavior outcomes. In addition we will use mediation and cost-effectiveness analyses to further examine the change mechanisms and the utility of the brief interventions tested in the proposed research. Results of the proposed study will guide the allocation of HIV prevention resources in establishing brief and effective HIV risk reduction counseling services for populations vulnerable to HIV infection.

This application is in response to the RFA "Communications and HIV/STD Prevention" (RFA MH 01003) and requests 4 years of support to conduct a randomized trial of an intervention designed to improve health behaviors and quality of life among people living with HIV- AIDS. This secondary prevention study will determine whether a motivational-skills building intervention, guided by the Information- Motivation-Behavioral Skills (IMB) Model of health behavior change, increases personal capacity to access and effectively use information available on the Internet to empower the practice of health behaviors and improve health outcomes in people living with HIV-AIDS. The communications revolution has expanded the universal availability of information and created opportunities for millions of people with access to the Internet. Access to health communications and resources via the Internet has also demonstrated positive health outcomes for people with chronic illnesses. However, African-Americans, women, and the inner- city poor are at considerable disadvantage for using information technologies due to limited education, limited exposure to computers, and a sense of disconnection from advances in technology. The demography of AIDS suggests, and our preliminary studies confirm, that there is a significant information gap, or digital divide, between persons with HIV-AIDS who have and those who do not have sufficient information technology skills to use the Internet. The proposed research will test the efficacy of an information technology motivational-skills building intervention to improve information consumer skills and health benefits of information resources available via the Internet. The study will recruit, assess, and randomly assign 225 HIV positive men and 225 HIV positive women from community service agencies who possess at least a 6th grade reading level to receive either (a) 10-session motivational-skills building intervention designed to increase effective use of information technology; or (b) 10-session standard educational comparison group; or (c) 2-session minimal intervention control group. Participants will be followed for 12-months to assess the effects of the information technology motivational-skills building intervention on motivation to use the Internet, Internet use, health knowledge, internal health locus of control, social support, problem focused coping, health behaviors, health-related quality of life, and mental health outcomes. We will also test a mediation model based on the IMB model of health behavior adapted for Internet use and information consumer skills. In addition, we will examine the characteristics of HIV infected persons who utilize and benefit from increased access to information available on the Internet and identify personal and social factors that impede and facilitate use of information resources. If successful, the experimental intervention could be readily implemented as a community-based program by AIDS Service Organizations, health centers, and community-based Internet access providers.

[unreadable] DESCRIPTION (provided by applicant): This revised proposal requests 4 years of support to conduct developmental research to design and field-test a gender and theory-based behavioral risk reduction intervention for men who are at risk for perpetrating violence against women and at risk for contracting and transmitting HIV in Cape Town, South Africa. As many as one in five South Africans is HIV positive and there are an estimated 1,600 new HIV infections in South Africa each day. South Africa also has the world's highest rates of violence against women and sexual coercion is associated with women's increased risks for HIV infection. Guided by the social constructionist theory of gender and the Information-Motivation-Behavioral Skills model of health promoting behaviors we will conduct 3 stages of intervention development research: (Stage 1) initial interviews, focus groups, and quantitative surveys with men and women in a community center in a Cape Town township. Based on information gained from rapid formative studies, this first phase of research will develop a theory-based gender-based violence and HIV-related risk reduction intervention; (Stage 2) Test the feasibility of the newly developed intervention with a small sample of men and receive feedback on the intervention content from women in the community. Stage 2 will also test the feasibility of an audio-computer assisted interview for data collection in the community center; and (Stage 3) Conduct a randomized field test to determine the potential efficacy of the risk reduction intervention for South African men at risk for gender-based violence and HIV. Participants in the field test will be randomly assigned to either receive the newly developed intervention or a time matched attention comparison condition. Following a 6-month follow-up period, we will assess differences between groups on behavioral outcomes. We will also test the moderating effects of gender-based attitudes and beliefs on HIV risk reduction constructs and intervention outcomes. Results of the proposed research will also provide critical information about the role of gender power differentials, attitudes toward women, and AIDS stigmas in HIV transmission risks in South Africa and will offer urgently needed strategies for improving HIV prevention interventions in South Africa. [unreadable] [unreadable]

DESCRIPTION (provided by applicant): This research proposal is in response to the Request for Applications "Alcohol Abuse and HIV/AIDS in Resource-Poor Societies" (RFA-03-009) and requests 3 years of support to conduct developmental research to design and field test a theory-based behavioral risk reduction intervention for men and women who use alcohol and are at-risk for HIV infection in the Western Cape of South Africa. As many as one in five South Africans is HIV positive and there are an estimated 1,500 new HIV infections in South Africa each day. Guided by the Information-Motivation-Behavioral Skills model of health promoting behaviors we will conduct 3 phases of intervention development research: (1) Initial interviews, focus groups, and quantitative surveys with men and women who use alcohol and are at risk for HIV transmission in a Black township in Cape Town South Africa. Based on information gained from rapid formative studies, this first phase of research will develop a theory-based alcohol related risk reduction intervention tailored for use in HIV voluntary testing and counseling contexts in South Africa; (2) Test the feasibility of the newly developed alcohol related HIV risk reduction intervention with a small sample of men and women who use alcohol and engage in risky behavior; and (3) Conduct a randomized field test to determine the potential efficacy of the alcohol risk reduction intervention for South African men and women. Participants in the field test will be randomly assigned to either receive the newly developed intervention or assigned to a time matched attention comparison condition. Following a 6-month follow-up period, we will test for differences between groups on behavioral outcomes. We will also test the mediating effects of information, motivation, and behavioral skills constructs on intervention outcomes. Results of the proposed research will provide critical information about the role of alcohol in HIV transmission risks and will offer urgently needed strategies for improving HIV prevention interventions in South Africa.

DESCRIPTION (provided by applicant): This 5 year study will conduct a randomized clinical trial of a gender and culturally tailored theory-based behavioral risk reduction intervention for men and women who are receiving sexually transmitted infection (STI) diagnostic and treatment services from two different types of STI treatment providers in two provinces in South Africa. As many as one in five South Africans is HIV positive and there are an estimated 1,500 new HIV infections in South Africa each day. The experimental intervention in this study was developed by South African and US investigators and pilot tested in South Africa. The intervention is grounded in the experience of South African health service providers, Social Constructionist Theory of Gender, empirical research on AIDS-related stigmas, and elements of a social cognitive theory of health behavior change. The intervention consists of a single 60-minute risk reduction counseling session delivered within the context of STI services. The study will recruit 200 men and 200 women from four STI clinics (N = 1600), two dedicated STI clinics in urban centers and two primary care clinics in townships. Participants will be STI clinic patients over age 18 that have been treated for a previous STI. Participants will be baseline assessed and randomized to receive either (a) the 60 min theory-based and culturally tailored risk reduction intervention or (b) a time and contact matched standard of care HIV and health education session. Participants will be followed for 15 months post intervention. Assessments will be conducted using computer assisted interviews (ACASI). The randomized trial will determine the efficacy of the risk reduction intervention for South African men and women receiving STI clinic services. Outcome analyses will include differences between .conditions on new STI diagnoses over 15 months. We will also test the mediating effects of gender attitudes and beliefs, AIDS stigmas, information, motivation, and behavioral skills constructs on intervention outcomes. Results of this research will therefore test a clinic-based HIV prevention intervention model that is urgently needed in South Africa.

DESCRIPTION (provided by applicant): Non-adherence to antiretroviral medications can lead to the development of treatment resistant genetic variants of HIV, which can then be transmitted to sexual risk partners. This application proposes to test a theory-based behavioral intervention to simultaneously improve HIV treatment adherence and reduce HIV transmission risk behaviors in people living with HIV-AIDS. Grounded in the Information - Motivation - Behavioral Skills (1MB) model of health behavior change, the experimental intervention will be delivered in a mixed format model with four group sessions followed by two individual counseling sessions conducted by community-based group facilitators. The intervention will be conducted at an AIDS service organization in Atlanta. Men (n = 225) and women (n = 225) will be recruited from a variety of AIDS services and infectious disease clinics. Following informed consent and baseline assessments, participants will be randomly assigned to receive either the (a) integrated HIV treatment adherence - risk reduction intervention or (b) a time matched non-contaminating standard of care comparison intervention. Participants will be followed over the course of a 12-month observation period. Assessments will include measures of information, motivation, and behavioral skills pertaining to HIV treatment adherence and HIV transmission risks and risk reduction, self-report and objectively assessed medication adherence, sexual transmission risk behaviors, and viral load, and CD4 cell counts. The study will test the hypothesis that a unified, integrated theory-based HIV treatment and risk reduction intervention will improve HIV treatment adherence, reduce HIV transmission risk behaviors, and improve health. The study will also examine the influence of 1MB theoretical constructs on intervention outcomes. Changes in behavior that coincide with and predict maintenance of change and relapse to non-adherence and risk behaviors in relation to changes in viral load over the 12-month follow-up period will also be a focal point of the study. The intervention under investigation will be among the first to simultaneously address treatment adherence and sexual risk behavior in an integrated model derived from a single, unified theory of health behavior. If shown effective, the intervention model will have implications for community and clinical services for people living with HIV-AIDS.

[unreadable] DESCRIPTION (provided by applicant): AIDS behavioral research has benefited from the contributions of social psychology and there is a need for training social psychologists committed to AIDS research. The proposed training program will integrate three core areas of social psychological studies with state of the art AIDS behavioral research. During the proposed 5-year training program, we will recruit and train 14 predoctoral students in social processes of AIDS theories, research methods and applications. The Objectives of the 3-year training period are to: (1) Train doctoral candidates in one of the three integrated models of HIV/AIDS and basic social behavioral research through a structured program and dual mentorship; (2) Provide trainees with community field research skills relevant to conducting community-based HIV/AIDS behavioral research; (3) Facilitate innovative research ideas in three core areas of HIV/AIDS behavioral research; (4) Have trainees complete an independent field research project in collaboration with an AIDS service provider; (5) Provide trainees with skills and experience in grant writing. All trainees in the program will be dually mentored in AIDS behavioral sciences by one of five Faculty dedicated to AIDS behavioral research and one Faculty member from one of three core-related areas: (a) interpersonal relationships, couples, groups and other dyadic processes, (b) social inequality and social disparities, including psychological consequences and correlates of social disenfranchisement, marginalization, discrimination, and stereotyping, and (c) social psychological aspects of gender relations and stigmatizing beliefs and behaviors. Blending HIV/AIDS behavioral studies with core theoretical research on dyadic processes, social inequality, and gender and stigma will yield new and innovative approaches to addressing some of the most compelling contemporary challenges related to AIDS intervention and prevention. We will forge new avenues in dyadic processes of HIV risks and relationships, social aspects of poverty and disparities among people at risk as well as those living with HIV/AIDS, gender relations and gender power imbalances in relation to HIV risks, and social processes related to AIDS stigma. Trainees will be supported for 3 years and will complete extensive training in research design, quantitative methods, substantive courses from different general areas of social psychology, courses from other areas of psychology, and courses from related disciplines including public health, sociology, anthropology, etc. Program trainees will be expected to make research presentations at national or international conferences, publish original research, and will write a grant proposal. The program will also center around training in community-based field research that includes a service oriented research experience. Trainees will work with a community based AIDS service organization to conduct a field study that will serve as a rich training experience for them and will directly benefit the partner organization. [unreadable] [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): This project will conduct a randomized community-level trial of a theory-based and culturally tailored multilevel HIV/AIDS risk reduction intervention for men and women who drink alcohol in informal drinking establishments (shebeens) in Cape Town South Africa. As many as one in five South Africans is HIV positive and there are an estimated 1,500 new HIV infections in South Africa each day. The multilevel intervention we are testing is grounded in Social Action Theory and incorporates behavioral skills for HIV risk reduction, risk-related alcohol use, and social communication skills for community activation. The intervention consists of three weekly 3-hour group workshops with a community-level intervention component. We will recruit 75 men from shebeens in 12 impoverished neighborhoods (N=900). The neighborhoods will be matched on key characteristics and randomly assigned to either (a) the multilevel HIV/alcohol risk reduction intervention or (b) a time-matched HIV/alcohol information-only education control condition. Participants will be enrolled using chain recruitment to reach men who drink in shebeens and engage in high-risk sexual activities. Following community level randomization, participants will be baseline assessed, intervened with, and followed for 12 months post intervention. We will also monitor changes in alcohol expectancies, AIDS stigmas, social norms and other social environmental factors among men who did not participate in the intervention workshops and women recruited from the same shebeens. Multilevel modeling will test the associations of environmental and individual changes in alcohol use, social norms, alcohol expectancies, and sexual risk behaviors over time. This community level randomized trial will determine the efficacy of a risk reduction intervention for South Africans who drink and are at high-risk for HIV. The study will directly test the effects of alcohol-related social influences at the community level on behavior change and maintenance of change at the individual level. Alcohol is associated with sexual risks for HIV/AIDS in South Africa. Interventions aimed at reducing HIV transmission among individuals who drink alcohol have short-lived effects. Interventions that target both individual and social environmental level behavior change may result in greater and sustained HIV risk reduction. This study will test the effects of a multilevel alcohol and HIV risk reduction intervention for South African men who drink at informal alcohol serving establishments (e.g., shebeens). We will examine community-level intervention effects for men not attending the intervention sessions as well as women sampled from the shebeens. This research will determine social and alcohol contextual influences at the community level that predict individual behavior change over-time.

[unreadable] DESCRIPTION (provided by applicant): Adherence to antiretroviral medications is necessary to achieve sufficient HIV suppression and non- adherence can lead to the development of treatment resistant genetic variants of HIV. Research has demonstrated that people living with HIV/AIDS who have low-levels of health literacy experience greater treatment non-adherence than their higher-literacy counterparts. Interventions are urgently needed to improve treatment adherence in people with poor literacy skills. This application proposes to test a theory- based behavioral intervention for improving HIV treatment adherence in people living with HIV/AIDS who have low-literacy skills. Grounded in the Information Motivation Behavioral Skills (IMB) model of health behavior change, the experimental intervention has been tailored for people with low-levels of health literacy and has been pilot tested in preliminary intervention development research. The intervention is delivered in three one-on-one counseling sessions and one maintenance-focused booster session. The intervention will be conducted in a community care setting in Atlanta. Men (n = 225) and women (n = 225) will be recruited from a AIDS services and infectious disease clinics throughout the Atlanta metropolitan area. Following screening, informed consent and baseline assessments participants will be randomly assigned to receive one of three conditions: (a) Theory-based literacy tailored treatment adherence intervention; (b) standard of care non-tailored time-matched adherence counseling intervention; (c) non- contaminating time-matched attention control intervention. Participants will be followed for 12-months observation. Assessments will include measures of information, motivation, and behavioral skills pertaining to HIV treatment adherence, self-report and objective medication adherence, and viral load. The study will test the hypothesis that a theory-based HIV treatment adherence intervention that is tailored for people with low-literacy will improve HIV treatment adherence and health relative to the standard and attention control conditions. The study will also examine the influence of IMB theoretical constructs on intervention outcomes. The intervention under investigation will be among the first to address treatment adherence among people with poor literacy skills. If shown effective, the intervention model will be ready for immediate dissemination to clinical and community adherence enhancement services for people living with HIV-AIDS. Consistent adherence to antiretroviral therapy is necessary for treatment success. People with poor health literacy skills experience considerable difficulty adhering to their medications. Effective strategies for improving adherence in patients with poor health literacy must be tailored to achieve optimal adherence and therefore viral suppression. [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): This project will conduct a multilevel prospective analysis of alcohol-related HIV/AIDS risks among women who drink in alcohol serving establishments (shebeens, taverns and bottle stores) in Cape Town South Africa. As many as one in five South Africans is HIV positive and there are an estimated 1,500 new HIV infections in South Africa each day. Research consistently shows that alcohol is closely related to HIV transmission risks in southern Africa, although most research in drinking establishments has focused on men. Our proposed multilevel analysis is grounded in Social Action Theory and incorporates factors derived from three levels of analysis: structural/environmental, social/interpersonal, and individual. We propose collecting environmental level data from two informal drinking places (shebeens), two larger drinking places (taverns), and businesses that sell and do not serve alcohol (bottle stores) in two racial/cultural communities (Black Africans of Xhosa heritage and mixed racial background Coloured), for a total of 12 drinking establishments. Data will be collected from key informants (n=20), alcohol serving business owners, managers and servers (n=60), interviews (n=240) and cross-sectional surveys (n= 900) of men and women drinkers, and a prospective cohort of women (n=300). Assessments at the structural/environmental, social/interpersonal, and individual levels will be collected at 4 time points: baseline, 4-, 8-, and 12-months. We will test the associations of alcohol serving establishment characteristics, socioeconomic conditions, gender dynamics, social norms and collective efficacy, and individual risk characteristics including alcohol expectancies and risk reduction self-efficacy of women who drink in the target settings. We will use multilevel modeling to test whether contextual factors, including socioeconomic conditions and drinking setting characteristics, directly predict social interactions and social dynamics of women's risks for HIV/AIDS. We will also examine characteristics of drinking settings, propensity for gender violence, and men's gender attitudes in relation to women's alcohol-related HIV risks. We also propose conducting a series of intervention development activities that will be informed by our multilevel study, providing a new intervention model as the study end-product available for subsequent testing. The proposed study will therefore directly meet the urgent need for new multilevel HIV prevention intervention models for women who drink in alcohol serving establishments in South Africa. PUBLIC HEALTH RELEVANCE: Alcohol is associated with sexual risks for HIV/AIDS in South Africa. Research has shown that men who drink at alcohol serving establishments are at high risk for HIV transmission, but little research has focused on South African women who drink in these settings. Structural/environmental, social/interpersonal, and individual level factors influence alcohol use and risk behavior, although the complex interplay of these factors has not been examined among women who drink. This study will test a multilevel model of alcohol and HIV risks among African and Coloured women in South Africa using a prospective study design. Multilevel risk factors will be examined at small informal alcohol serving establishments (shebeens), larger more formal drinking places (taverns), and alcohol sales business (bottle stores). Guided by Social Action Theory, we will examine structural, social, and individual level influences on women's drinking and HIV risks.

DESCRIPTION (provided by applicant): This application addresses the broad challenge area of (06) Enabling Technology and the specific challenge topic 06-OD(OBSSR)-101 Using new technologies to improve treatment adherence. Strict adherence to antiretroviral medications is necessary for people living with HIV/AIDS to achieve sufficient viral suppression to slow disease and alcohol use is a known barrier to medication adherence. Alcohol intoxication effects memory, attention, and other basic cognitive functions that are obviously linked to missing medications. In addition, drinking can affect adherence the day after intoxication due to hangover impairments. Less is known about how alcohol-related beliefs interrupt treatment, such as when individuals believe that they should stop taking their medications to avoid mixing them with alcohol. Believing that mixing alcohol with medications leads to adverse reactions (interactive toxicity beliefs) can result in patients deliberately stopping their HIV therapy. Thus, HIV positive individuals who drink may experience prolonged and dangerous treatment interruptions due to their beliefs about alcohol. There are few studies of alcohol expectancies, including interactive toxicity beliefs, in relation to medication adherence. We propose a 12- month prospective cohort study to examine interactive toxicity beliefs in relation to HIV treatment adherence. Our model predicts that quantity and frequency of alcohol intake will be associated with non- adherence to HIV treatments. We also predict that drinkers who believe that mixing alcohol and HIV medications is toxic will interrupt their therapy when drinking. We hypothesize that interactive toxicity beliefs will predict non-adherence to treatment over and above common factors associated with non- adherence, including quantity and frequency of alcohol consumption. The study will include an innovative combination of reliable and valid technologies for objectively monitoring HIV treatment adherence and alcohol consumption. A cohort of 200 men and women who are (a) taking HIV medications and (b) report drinking alcohol in the previous month will be enrolled in a 12-month prospective cohort. Participant's alcohol and other drug use as well as HIV treatment adherence will be monitored using cell-phone-based assessment technologies. To monitor HIV treatment adherence, we will use unannounced pill counts conducted every 3 to 4 weeks. Alcohol and other drug use will be monitored using daily interactive voice response technology. Multilevel modeling will test a model of interactive toxicity beliefs in relation to alcohol use and medication adherence over a one year period. Our findings will inform interventions to address alcohol use and HIV treatment adherence in HIV/AIDS patients who drink. The benefits of HIV treatment are only realized with persistent strict adherence and alcohol is a known barrier to medication adherence. Alcohol intoxication effects memory, attention, and other basic cognitive functions that obviously lead to missing medication doses. In addition, beliefs that mixing alcohol with medications will result in adverse reactions (interactive toxicity beliefs) may cause particularly hazardous prolonged interruptions in HIV treatment. Beliefs about alcohol and HIV treatments may contribute to the development and spread of treatment resistant virus representing a significant threat to public health as well as personal health.

DESCRIPTION (provided by applicant): This application tests a theory-based HIV treatment adherence intervention delivered by cell phone to patients in urban and rural areas. Adherence to antiretroviral (ART) medications is necessary to achieve HIV suppression and non-adherence can lead to treatment resistant genetic variants of HIV. People living with HIV/AIDS often experience difficulty sustaining high-levels of treatment adherence. Most factors that interfere with adherence are unanticipated and occur between clinical visits, including depression, side effects, substance use, and lapses in pharmacy refill. We will conduct a randomized clinical trial to test a cell phone-delivered theory-based medication adherence counseling intervention. The intervention is grounded in Self-Regulation Model and utilizes unannounced pill counts to monitor adherence and guide corrective feedback within the counseling context. Using pill count adherence information for counseling allows providers to detect and correct patient non-adherence within a time frame that can head off viral resistance. An experimental factorial design will test the effects of counseling and a text message reminder system as well the interaction of counseling and text message components with 600 men and women receiving HIV treatment. Following screening, informed consent and baseline assessments participants will be randomized to one of four intervention conditions:(a) self-regulation counseling + regimen tailored text message reminders; (b) self-regulation counseling + control messages; (c) control counseling + regimen tailored text reminders; or (d) control counseling + control messages. The study will therefore use a 2 (self-regulation counseling) x 2 (text message reminders) full factorial deign with participants followed for 12 months post-intervention. The primary endpoints are medication adherence assessed by unannounced pill counts and HIV RNA (viral load). This newly developed intervention strategy is grounded in Self-Regulation Theory and is designed for use in clinical settings with limited resources.

DESCRIPTION (provided by applicant): Prevention strategies that aim to test and treat people for HIV infection are undermined by HIV treatment non-adherence and sexually transmitted co-infections (STI). Scalable interventions are urgently needed to sustain low infectiousness by improving HIV treatment adherence and reducing risks for transmitting HIV. This application proposes to test a theory-based behavioral intervention to simultaneously improve HIV treatment adherence and reduce HIV transmission risk behaviors in people living with HIV/AIDS who use alcohol and other drugs. Grounded in Conflict Theory of Decision Making, the intervention will be delivered in a mixed format, with one office-based counseling session followed by four cell phone delivered counseling sessions. The intervention will be conducted in Atlanta and surrounding impoverished areas. Men (n = 250) and women (n = 250) receiving HIV treatment will be recruited from AIDS services and infectious disease clinics. Following informed consent and baseline assessments, participants will be randomly assigned to either an (a) integrated HIV treatment adherence - risk reduction intervention or (b) a time-matched non-contaminating attention control condition. Participants will be followed for 12-months using office-based computerized interviews, unannounced pill counts, and medical chart abstraction. The study will test the hypothesis that a unified, integrated theory-based HIV treatment and risk reduction intervention will reduce HIV transmission risk behaviors, improve HIV treatment adherence, reduce viral load and prevent new STI. The study will also examine the influence of theoretical constructs and structural barriers on intervention outcomes. Factors that predict relapse to non-adherence and risk behaviors in relation to changes in viral load and STI over the 12-month follow-up period will also be a focal point of the study. The intervention under investigation will be among the first to simultaneously address treatment adherence and risk behavior in an integrated model for substance using HIV positive men and women. If shown effective, the intervention model will be ready for immediate dissemination to community and clinical services for people living with HIV/AIDS.

DESCRIPTION (provided by applicant): This 5-year study will conduct a randomized clinical trial of a culturally tailored theory-based behavioral risk reduction and enhanced partner notification intervention for men and women who are receiving sexually transmitted infection (STI) diagnostic and treatment services in South Africa. Among the world's most severe HIV epidemics, as many as one in five South Africans living in the most affected areas are HIV positive. The experimental intervention in this study is grounded in social-cognitive theories of health behavior change and has been pre-tested in preliminary research. The intervention consists of a single 60-minute risk reduction counseling session with behavioral skills building components to enhance partner communication skills for improved partner notification. The study design includes two comparison conditions: behavioral risk reduction counseling without partner communication and notification skills enhancement, and a standard didactic health information condition. We will recruit 525 men and 525 women from a large STI clinic in Cape Town. Participants will be STI clinic patients age 18 or older who are receiving STI services. Participants will be baseline assessed and randomized to receive either (a) the 60-minute theory-based and culturally tailored risk reduction and partner communication/notification intervention; (b) a 60-minute risk reduction counseling intervention without partner communication/notification components; or (c) a time and contact matched 60-minute standard didactic health information session. Participants will be followed for 12 months post intervention. The study will test intervention effects on two primary endpoints: contracting new STI and objectively measured partner notification events. The randomized trial will determine the efficacy of the risk reduction intervention for South African men and women receiving STI clinic services. We will also test the mediating effects of partner notification on STI outcomes. Results of this research will therefore test a clinic-based HIV prevention intervention model that is urgently needed in South Africa.

DESCRIPTION (provided by applicant): This research proposal requests 3 years of support to conduct developmental intervention studies to design and field test a theory-based intervention to address food insecurity and improve antiretroviral therapy (ART) adherence among men and women living with HIV infection. Food insecurity is prevalent among people living with HIV in US inner-cities, with as many as 43% not having sufficient food and experiencing intermittent hunger. Food insecurity has demonstrated direct associations with ART adherence including predicting non-adherence over and above other factors including depression, social support, and alcohol use. Food insecurity is particularly problematic in relation to substance abuse given competing survival needs and the dire combined health consequences of alcoholism, addiction and malnutrition. Guided by the Conservation of Resources Theory of Stress and Coping, we will conduct 3 stages of intervention development research: (1) initial interviews and focus groups with people living with HIV who take ART, use substances, and experience food insecurity. Based on information gained from rapid formative studies, this first stage of research will be used to develop a theory-based intervention to address accessing food and sustaining ART adherence; (2) Test the feasibility of the newly developed food insecurity and adherence intervention with a small sample of HIV positive men and women who are taking ART, use substances, and experience food insecurity. Stage 2 will also finalize and pilot test all assessment instruments and protocols for data collection; and (3) Conduct a randomized field test to determine the potential efficacy of the food insecurity and ART adherence intervention. Participants in the field test will be randomly assigned to either receive the newly developed intervention or a time matched attention comparison condition. Following a 6- month follow-up period, we will test for differences between groups on ART adherence, food access, nutrition, and coping resource outcomes. The intervention development will include pilot testing daily food, mood, and substance use behaviors monitored by interactive text-message surveys. We will also examine the intervention effects on mediating theoretical constructs derived by Conservation of Resources Theory. Our developmental research will also examine the feasibility and acceptability of conducting the intervention in face-to-face intervention sessions. The proposed intervention research will therefore develop new strategies for use with people living with HIV who are taking ART under adverse conditions with multiple competing needs.

DESCRIPTION (provided by applicant): This research will compare two delivery formats for effective individually-tailored behavioral self-regulation counseling - clinic-based vs. cell phone delivered - to improve treatment retention and adherence in people living with HIV in resource limited small cities and rural areas. Engagement, retention, and adherence to care are necessary to achieve HIV suppression and the long-term clinical management of HIV infection. Unfortunately, substance use, poverty, and other barriers impede the clinical care and compromise the health of many people living with HIV infection. Only about half of people with known HIV infection in the United States are retained in care and only one in five achieve successful viral control, a pattern that is known as the HIV treatment cascade. We will conduct comparative effectiveness research (CER) on two models of clinical intervention delivery using either (a) clinic office visit counseling or (b) cell phone-delivered counseling. Behavioral self-regulation counseling is an evidence-based individualized patient care approach to monitoring adherence, providing support, and offering guided corrective feedback to improve medication adherence and retention in care. This proactive intervention is designed to increase engagement in care, facilitate retention, maximize adherence and improve health outcomes. Behavioral self-regulation counseling has been demonstrated effective in both clinic-based and phone-delivered formats. However, the comparative costs and effectiveness of these alternative formats for delivering behavioral interventions in clinical care have not been tested. Our aim is to conduct comparative effectiveness research on behavioral self-regulation counseling to guide health policy and clinical resource decision-making. Participants are 200 men and 200 women living in high-HIV prevalence remote communities who actively use alcohol or other drugs and are receiving HIV treatment. Following screening, informed consent, and baseline assessments, participants will be allocated to receive either (a) behavioral self-regulation counseling integrated into their office-based care or (b) behavioral self-regulation counseling delivered at home by cell phone. Participants will be followed for 12-months following implementation. The primary endpoints are mapped onto the HIV treatment cascade and include a biomarker for alcohol use, clinic-confirmed retention to care, medication adherence assessed by unannounced pill counts, and HIV RNA (viral load). The study includes implementation research that will determine facilitators and barriers to clinic and cell phone implementation and cost accounting of resources expended to achieve optimal outcomes. A team of internationally recognized experts will form a working group to guide the operational evaluation at minimal added cost. This study will inform evidence- based care retention and adherence interventions for people living with HIV who are using alcohol or other drugs in resource limited settings.

This pragmatic adaptive clinical trial will test the effects of a Stigma-Motivational-Decision intervention designed to increase HIV treatment engagement, retention, and medication adherence for substance using adolescents and young adults (AYA) living with HIV who are not in clinical care. The intervention uses a uniquely unified counseling approach at multiple points along the HIV continuum of care. In a first step, we will use multiple modes of outreach including social media, passive media, clinic records, and chain referrals to seek and identify HIV positive AYA (age 16 to 25) who are out of HIV care. In Step 2, HIV positive AYA who are out of HIV care and substance using will be enrolled in a phone-delivered counseling intervention to address substance use, HIV stigmas, medical care-related concerns, structural barriers, and other challenges to engaging youth in HIV care. Counseling will be provided weekly until the time participants are engaged in care, with a maximum of 12 sessions (up 3-months). We will therefore determine the number of theory-based phone intervention sessions needed (minimally effective dose) for care engagement and the associated costs. Once engaged in care, Step 3 will conduct a randomized trial to test the comparative effects and cost effectiveness of interactive text messaging with opportunities for ongoing supportive problem solving versus text message reminders to sustain long-term retention in care and medication adherence. HIV positive AYA are likely to drop out of care because of known challenges such as substance use, social barriers such as stigma, and concerns regarding treatment. Our 3-step study will use a single theory-based approach to determine the number of phone-delivered Stigma-Motivational-Decision counseling intervention sessions necessary to achieve engagement or re-engagement in HIV care, and will test the effects of a low-cost approach to sustaining long-term retention in care and medication adherence. Participants will be out of care at baseline and counseled with up to 12 weekly phone-delivered intervention sessions until they confirm engagement in HIV care. The study will determine the minimally effective counseling dose needed to engage substance using HIV positive AYA in care. Once participants attend HIV medical appointments, they will be randomized to either: (a) 15-months of ongoing weekly mobile phone text message check-ins with the opportunity for brief problem-focused phone support or (b) weekly text message reminders. The study will test the effects of the counseling and text messaging interventions on maintaining HIV care retention, medication adherence, and HIV viral suppression over 18-months. The primary endpoint in this trial is HIV RNA suppression. We will perform economic evaluations to determine the cost-effectiveness of the engagement-retention-adherence intervention. The proposed pragmatic adaptive trial will therefore determine the minimally effective dose of counseling and the effects of a low-burden retention/adherence intervention to maintain retention in care and avoid relapse to non-adherence for AYA living with HIV.

HIV incidence among Black men who have sex with men (BMSM) in the southeastern United States is among the highest in the world. Current trends show that as many as 60% of BMSM will contract HIV by the age of 40 and nearly half (46%) of BMSM who are living with HIV in the US are undiagnosed. Infrequent HIV testing and the poor uptake of evidence-based approaches to preventing HIV by BMSM, particularly HIV pre- exposure prophylaxis (PrEP), constitutes a public health crisis. Among the factors that impede HIV prevention for BMSM, including HIV testing and linkage to PrEP, are the social stigmas and discrimination based on race, sexual orientation and HIV-risk. Furthermore, combinations of stigmas, including race, sexual orientation and HIV-risk intersect to shape unique experiences such that BMSM are stigmatized not just through racism and homophobia, but by the unique experiences of being a Black man who engages in same- sex sexual behaviors. Stigmatized characteristics intersect within individuals, a concept known as intersectional stigma; the juncture of multiple stigmatized characteristics including race, sexual orientation and HIV-risk. However, there are few measures of intersectional stigma and none are designed for use in HIV prevention with BMSM. Reliable and valid measures of internalized, anticipated, and enacted stigmas that encompass the concept of intersectionality are needed to improve HIV prevention intervention research. The proposed research will meet the need for measures of intersectional stigma by developing and testing a novel and parsimonious approach to assessing intersectional internalized, anticipated, and enacted stigmas. This research is grounded in the HIV Stigma Framework and will capitalize on standard computerized interviewing to administer assessments of internalized, anticipated and enacted stigmas attributed at the item-level to multiple personal characteristics (race, sexual orientation, and HIV-risk). Two studies will be conducted to test the reliability and validity of this innovative approach to simultaneously assessing multiple stigma dimensions. Study 1 will perform rigorous psychometric analyses and confirmatory factor analyses to establish the reliability and concurrent validity of the intersectional stigma scales in a sample of 500 BMSM who have not been tested for HIV in the previous 6-months and meet the CDC criteria as a candidate for PrEP but have never been prescribed PrEP. Study 2 will serve to cross-validate scale reliability and concurrent validity and determine the time stability (test-retest reliability) and predictive validity of the intersectional stigma scales in a sample of 300 BMSM meeting the same criteria described above. Participants in Study 2 will be assessed twice over a 4-month period. Regression models will test the predictive validity of the scales, specifically predicting HIV testing, PrEP interest and PrEP uptake over 4-months. Findings from the two-years of research will yield a new approach to measuring intersectional stigma to advance HIV testing, PrEP use, and other prevention interventions targeted to BMSM and other stigmatized groups.

The proposed research will conduct the first ever dose-determination trial of a behavioral intervention to improve engagement in HIV care, antiretroviral therapy (ART) adherence and HIV viral suppression. The trial is designed to inform the implementation of behavioral interventions, including several in CDC?s Compendium of Evidence-Based Interventions. Behavioral counseling has the flexibility and reach to overcome numerous challenges to HIV care, including social, emotional, and structural barriers. However, basic questions of how to best implement and scale-up interventions remain unanswered, such as ?how much intervention is needed to achieve HIV suppression in subgroups of patients facing individual and social challenges?? There are currently no dose-determination trials in the HIV behavioral intervention literature to guide implementation decisions and health service policy. In the proposed research we specifically aim to: (a) determine the minimum effective dose of an evidence-based HIV treatment engagement and adherence intervention, (b) identify subgroups of patients requiring greater and fewer intervention resources to achieve and sustain viral suppression, and (c) the costs associated with intervention dose-response. Participants who are receiving ART and confirmed HIV unsuppressed (>200 copies/mL) will be randomized to either: (a) the dose determination condition of weekly evidence-based behavioral self-regulation counseling until achieving HIV suppression (<200 copies/mL), or (b) fixed dose 5-weekly sessions of evidence-based behavioral self-regulation counseling sessions. The dose determination condition adjusts to patient needs and determines the dose to achieve HIV suppression, in contrast to the fixed dose condition that does not adjust to patient response. The trial is therefore designed to determine the number of behavioral counseling intervention sessions needed to achieve and sustain HIV suppression. Once viral suppressed, counseling in the dose-determination condition is suspended. In contrast, the fixed-dose condition is delivered in five prescribed sessions as disseminated by the CDC. Follow-up assessments commence for 12-months from baseline with the primary endpoint of 12-month blood plasma HIV viral load and secondary outcome of ART adherence. Response to counseling is defined by achieving viral suppression (<200 copies/mL) and non-response is defined by not achieving viral suppression (>200 copies/mL). Participants in both the dose-determination and fixed-session conditions who initially respond and rebound to unsuppressed viral load will receive additional counseling with redose-response monitored and analyzed. Longitudinal analyses will examine intervention dose for key patient subgroups and dose-response cost-effectiveness analyses to guide resource allocation and implementation decisions. This research is aimed at informing health policy makers and programmatic decisions regarding intervention implementation to increase the likelihood of sustained HIV suppression.

The global scale-up of antiretroviral therapy (ART) is aimed to achieve 90% HIV suppression worldwide. However, even with increased access to ART, many countries are not on track to achieving this goal. Among the factors that impede retention in HIV care, ART adherence and HIV suppression is the social stigmatization of HIV infection. HIV stigmas and behaviors intended to avoid stigma have the adverse consequences of deterring people from seeking care, interfering with clinic attendance, and detracting from taking ART. Interventions to increase HIV care retention and ART adherence have not thus far focused on reducing the adverse effects of stigma in countries where HIV is most prevalent. This application proposes to test a theory-based mobile-phone delivered counseling intervention designed to address HIV-stigma concerns in order to improve HIV treatment retention and adherence in South Africa. The intervention is grounded in Behavioral Self-Regulation Theory and the HIV Stigma Framework and was developed in partnership with South African public health agencies. The intervention approach uses health decision- making and problem-solving skills aimed at resolving social and structural barriers to care, and is delivered by community health worker/lay counselors to increase its potential for scale-up. To test the efficacy of this newly developed and fully pilot tested intervention model, we will conduct a randomized clinical trial designed to tease-out the additive effects of directly addressing stigma concerns by augmenting a Behavioral Self- Regulation Counseling with stigma management components. We will conduct a 3-arm clinical trial in a resource limited township in South Africa that has shown evidence of high-HIV stigma to compare: (a) Behavioral Self-Regulation + Stigma Management Counseling for HIV treatment retention and adherence, vs. (b) Behavioral Self-Regulation Counseling for HIV treatment retention and adherence, vs. (c) Uniform standard of care HIV patient education. The trial will enroll 1200 men and women with unsuppressed HIV and receiving HIV treatment in South Africa?s HIV care system. Participants will be followed for 15-months post-intervention to assess intervention effects on HIV care retention and HIV suppression (primary outcomes) and ART adherence (secondary outcome). Conditional process modeling will determine underlying mechanisms (e.g., self-efficacy, behavioral strategies, internalized stigma, anticipated stigma) that account for intervention effects and how these mechanisms may vary by level of baseline experiences with enacted HIV stigma. The trial will also perform implementation research activities to inform potential scale-up should the intervention be shown efficacious. This newly developed intervention model is designed for use with existing clinical resources in WHO defined systems of differentiated HIV care.